U1 Hip System, Femoral Head 1201-1636

GUDID 04712771497434

U1 Hip System, Femoral head, OD 36mm, +7.5mm

UNITED ORTHOPEDIC CORP.

Metal-on-polyethylene total hip prosthesis

• Primary Device ID: 04712771497434
• NIH Device Record Key: b879879e-77b1-48eb-9642-31ba9cc110e4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: U1 Hip System, Femoral Head
• Version Model Number: 1201-1636
• Catalog Number: 1201-1636
• Company DUNS: 656700556
• Company Name: UNITED ORTHOPEDIC CORP.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +886229294567
• Email: service@uoc.com.tw

Device Dimensions

• Outer Diameter: 36 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	04712771497434 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122504

FDA Product Code

• LPH: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-08-02
• Device Publish Date: 2015-10-24

On-Brand Devices [U1 Hip System, Femoral Head]

• 04712771497434: U1 Hip System, Femoral head, OD 36mm, +7.5mm
• 04712771497427: U1 Hip System, Femoral head, OD 36mm, +2.5mm
• 04712771497410: U1 Hip System, Femoral head, OD 32mm, +7.5mm
• 04712771497403: U1 Hip System, Femoral head, OD 32mm, +2.5mm
• 04712771497397: U1 Hip System, Femoral head, OD 28mm, +7.5mm
• 04712771497380: U1 Hip System, Femoral head, OD28mm, +2.5mm
• 04712771483109: U1 Hip System, Femoral head, OD 36mm, +10mm
• 04712771483093: U1 Hip System, Femoral head, OD 36mm, +5mm
• 04712771483086: U1 Hip System, Femoral head, OD 36mm, +0mm
• 04712771483079: U1 Hip System, Femoral head, OD 36mm, -3mm
• 04712771483062: U1 Hip System, Femoral head, OD 32mm, +10mm
• 04712771483055: U1 Hip System, Femoral head, OD 32mm, +5mm
• 04712771483048: U1 Hip System, Femoral head, OD 32mm, +0mm
• 04712771483031: U1 Hip System, Femoral head, OD 32mm, -3mm
• 04712602341554: U1 Hip System, Femoral head, OD28mm, +10mm
• 04712602341547: U1 Hip System, Femoral head, OD 26mm, +9mm
• 04712602341523: 1201-1526
• 04712602341486: U1 Hip System, Femoral head, OD28mm, +5mm
• 04712602341479: U1 Hip System, Femoral head, OD 26mm,+3mm
• 04712602341431: U1 Hip System, Femoral head, OD28mm, +0mm
• 04712602341424: U1 Hip System, Femoral head, OD 26mm, +0mm
• 04712602341394: U1 Hip System, Femoral head, OD28mm, -3mm